Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors

PHASE3CompletedINTERVENTIONAL
Enrollment

325

Participants

Timeline

Start Date

January 19, 2006

Primary Completion Date

March 28, 2008

Study Completion Date

March 28, 2008

Conditions
Depressive Disorder
Interventions
DRUG

323U66 (Bupropion Hydrochloride Sustained Release)

Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.

DRUG

Placebo

Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.

Trial Locations (62)

462-0831

GSK Investigational Site, Aichi

470-1141

GSK Investigational Site, Aichi

475-0074

GSK Investigational Site, Aichi

270-1613

GSK Investigational Site, Chiba

802-0006

GSK Investigational Site, Fukuoka

810-0001

GSK Investigational Site, Fukuoka

814-0180

GSK Investigational Site, Fukuoka

816-0801

GSK Investigational Site, Fukuoka

816-0864

GSK Investigational Site, Fukuoka

960-0102

GSK Investigational Site, Fukushima

961-0021

GSK Investigational Site, Fukushima

963-0207

GSK Investigational Site, Fukushima

002-8029

GSK Investigational Site, Hokkaido

004-0052

GSK Investigational Site, Hokkaido

004-0841

GSK Investigational Site, Hokkaido

047-0155

GSK Investigational Site, Hokkaido

060-0042

GSK Investigational Site, Hokkaido

060-0061

GSK Investigational Site, Hokkaido

062-0922

GSK Investigational Site, Hokkaido

063-0061

GSK Investigational Site, Hokkaido

063-0804

GSK Investigational Site, Hokkaido

080-0014

GSK Investigational Site, Hokkaido

651-0092

GSK Investigational Site, Hyōgo

651-0097

GSK Investigational Site, Hyōgo

653-0841

GSK Investigational Site, Hyōgo

657-0846

GSK Investigational Site, Hyōgo

300-0812

GSK Investigational Site, Ibaraki

311-3193

GSK Investigational Site, Ibaraki

920-0939

GSK Investigational Site, Ishikawa

761-0793

GSK Investigational Site, Kagawa

213-0001

GSK Investigational Site, Kanagawa

223-0052

GSK Investigational Site, Kanagawa

225-0011

GSK Investigational Site, Kanagawa

231-0023

GSK Investigational Site, Kanagawa

238-0042

GSK Investigational Site, Kanagawa

861-8002

GSK Investigational Site, Kumamoto

390-8510

GSK Investigational Site, Nagano

639-0225

GSK Investigational Site, Nara

700-0941

GSK Investigational Site, Okayama

530-0026

GSK Investigational Site, Osaka

571-0048

GSK Investigational Site, Osaka

576-0054

GSK Investigational Site, Osaka

582-0025

GSK Investigational Site, Osaka

589-0011

GSK Investigational Site, Osaka

590-0018

GSK Investigational Site, Osaka

107-0052

GSK Investigational Site, Tokyo

108-0072

GSK Investigational Site, Tokyo

110-0005

GSK Investigational Site, Tokyo

114-0014

GSK Investigational Site, Tokyo

120-0033

GSK Investigational Site, Tokyo

141-0032

GSK Investigational Site, Tokyo

152-0012

GSK Investigational Site, Tokyo

154-0003

GSK Investigational Site, Tokyo

154-0004

GSK Investigational Site, Tokyo

160-0023

GSK Investigational Site, Tokyo

170-0002

GSK Investigational Site, Tokyo

170-0005

GSK Investigational Site, Tokyo

178-0063

GSK Investigational Site, Tokyo

194-0022

GSK Investigational Site, Tokyo

204-0022

GSK Investigational Site, Tokyo

682-0023

GSK Investigational Site, Tottori

683-8504

GSK Investigational Site, Tottori

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY